Executive Regulatory Affairs

5 days ago

Sachin Surat Gujarat, India Globela Laboratories Pvt Ltd Full time

**Name of the Department**

Regulatory Affairs

**Designation**

Regulatory Affairs Executive

**Qualification**:M. Pharm

**Reporting to**

Head
- Regulatory Affairs

**Primary Responsibilities**:
**1.** Provide responses to the regulatory agencies regarding Product information or issues.

**2.** Review and compilation of the dossiers data.

**3.** To coordinate with respective parties to resolve the queries as and when required.

**4.** Continuous follow up with Loan license party and fulfill the requirements of dossiers.

**5.** To prepare the dossiers as per respective country guidelines (CTD, ACTD and non CTD Format).

**6.** Assess product labels and patient information leaflets.

**7.** Develop regulatory strategies and implementation plans for the preparation and submission of new product.

**8.** Investigate product compliance and prepare documentation and submission to appropriate regulatory agencies as necessary.

**9.** To check the legalized documents and submit to clients on regulatory bodies

**10.** Proper communication with external and internal vendor.

**11.** To coordinate with respective parties to resolve the query as and when required.

**12.** Preparation of the process validation protocol and reports.

**13.** Preparation of the product development report.

**14.** Review of Vendor Qualification documents

**Secondary Responsibilities**:
**15.** Department in-time and out-time should be followed as decided by personal and administration department.

**16.** Maintain current knowledge of relevant regulations, including proposed and final rules.

**17.** Review of the Dossier’s data.

**18.** Ensuring that the company’s products comply with regulations of the WHO guidelines.

**19.** Working with specialist computer software and resources.

**20.** Manage activities such as audits, regulatory agency inspection or product bodies.

**21.** Daily and Monthly progress report.

**22.** Knowledge of business and Management principles involved in strategic planning, resource allocation, human resource modeling, leadership technique, production methods and coordination of people and resources.

**23.** The ability to work under pressure and strict deadlines.

**24.** To Coordinate with F&D department for registration sample preparation and submit samples to regulatory bodies on time.

Pay: ₹15,000.00 - ₹40,000.00 per month

**Benefits**:

- Paid time off

Schedule:

- Day shift

**Education**:

- Master's (required)

**Experience**:

- total work: 2 years (required)

Work Location: In person

Application Deadline: 31/12/2024
Expected Start Date: 08/01/2025

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